pk/pd/toxicology subject matter expert - Washington - Direct Staffing Inc

    Direct Staffing Inc
    Direct Staffing Inc Washington

    12 hours ago

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    Description

    PK/PD/Toxicology Subject Matter Expert (SME)

    We are seeking a highly experienced and knowledgeable PK/PD/Toxicology SME to support the development of medical countermeasures (MCMs) for CBRN, Influenza, and Emerging Infectious Diseases.

    Key Responsibilities

    1. Pre-Award Activities:
    • Provide subject matter expertise on pharmacology and toxicology studies, animal and clinical science models, analytical methods, and regulatory approaches applicable to an indication and utility of MCMs.
    • Develop initial statements of work (SOWs) and technical evaluation criteria to inform contract selections and design of studies.
    • Conduct product development cost analyses and generate formal independent government cost estimates for contract officers.
    • Participate in technical evaluation panels and pre-award negotiations with contract officers and program officials.
    1. Post-Award Efforts:
    • Serve as an advisor to project officers and support contract officers in conducting contract support, including weekly technical conference calls and site visits.
    • Evaluate and comment on weekly progress and provide supportive solutions as a technical representative for the project.
    • Review monthly and quarterly progress reports and provide comments on study issues, cost questions, and recommendations for solutions to identified problems.
    1. General Responsibilities:
    • Provide scientific and practical experience-based solutions to contract problems.
    • Support project officers in conducting contracts and provide scientific support to senior management as needed.
    • Offer technical briefings and educational support to project officers, project managers, and contract officers.

    Requirements

    1. At least 15 years of industry experience.
    2. Ph.D. or equivalent; M.S. acceptable with appropriate experience and professional licensing a plus.
    3. Professional publications related to drug development.
    4. Industrial experience with regulatory filings a major plus.
    5. Academic and professional peer recognition as an SME in toxicology or pharmacology.
    6. Active participation in professional societies a plus.

    Additional Information

    Direct Staffing Inc will maintain confidentiality of all submitted information according to EEO guidelines.



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